Search Results

The PASS LP Spinal Systems include a pedicle system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine:

• · Fractures
• · Dislocation
• · Failed previous fusion (Pseudarthrosis)
• · Spinal Stenosis
• · Degenerative spondylolisthesis with objective evidence of neurological impairment
• · Spinal deformations such as scoliosis or kyphosis.
• · Loss of stability due to tumors.

The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also include hooks and sacral/iliac screws indicated for degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyhosis, and/or lordosis), tumor. Pseudarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The UNiD Rods have to be used with the PASS LP Spinal System designed to contribute to correction and surqical stabilization of the thoracic, lumbar and sacral spine. The Patient Specific Rod is a rod bent before the surgery by MEDICREA, following the profile defined by the surgeon only, specific to a unique patient.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136 and ISO 5832-3 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

The purpose of this submission is to offer the existing cleared reference in sterile version.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

This Special 510(k) premarket notification is submitted for the additional offering of gamma sterilzed UNiD Rods.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification response from the FDA regarding the "PASS LP Spinal System." It details the device's classification, predicate devices, description, and indications for use. It does not include any performance data, clinical study results, or acceptance criteria.

Ask a specific question about this device